EP4748398A2 - Pharmazeutische formulierungen - Google Patents

Pharmazeutische formulierungen

Info

Publication number
EP4748398A2
EP4748398A2 EP26163516.3A EP26163516A EP4748398A2 EP 4748398 A2 EP4748398 A2 EP 4748398A2 EP 26163516 A EP26163516 A EP 26163516A EP 4748398 A2 EP4748398 A2 EP 4748398A2
Authority
EP
European Patent Office
Prior art keywords
cagrilintide
semaglutide
formulation
dose
concentration
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP26163516.3A
Other languages
English (en)
French (fr)
Other versions
EP4748398A3 (de
Inventor
Tommy SANDER
Christian Poulsen
Rosa Rebecca Erritzøe HANSEN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Novo Nordisk AS
Original Assignee
Novo Nordisk AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=74668840&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP4748398(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novo Nordisk AS filed Critical Novo Nordisk AS
Publication of EP4748398A2 publication Critical patent/EP4748398A2/de
Publication of EP4748398A3 publication Critical patent/EP4748398A3/de
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/26—Glucagons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4172—Imidazole-alkanecarboxylic acids, e.g. histidine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/26—Aristolochiaceae (Birthwort family), e.g. heartleaf
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests
    • A61M5/178—Syringes
    • A61M5/19—Syringes having more than one chamber
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Diabetes (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Inorganic Chemistry (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Endocrinology (AREA)
  • Biomedical Technology (AREA)
  • Obesity (AREA)
  • Molecular Biology (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Child & Adolescent Psychology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Emergency Medicine (AREA)
EP26163516.3A 2020-02-18 2021-02-17 Pharmazeutische formulierungen Pending EP4748398A3 (de)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
EP20157963 2020-02-18
EP20171240 2020-04-24
EP20180645 2020-06-17
EP20180832 2020-06-18
EP21150056 2021-01-04
EP21151004 2021-01-11
EP21154657 2021-02-02
PCT/EP2021/053805 WO2021144476A1 (en) 2020-02-18 2021-02-17 Pharmaceutical formulations
EP21706537.4A EP4106727A1 (de) 2020-02-18 2021-02-17 Pharmazeutische formulierungen

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
EP21706537.4A Division EP4106727A1 (de) 2020-02-18 2021-02-17 Pharmazeutische formulierungen

Publications (2)

Publication Number Publication Date
EP4748398A2 true EP4748398A2 (de) 2026-05-27
EP4748398A3 EP4748398A3 (de) 2026-08-12

Family

ID=74668840

Family Applications (4)

Application Number Title Priority Date Filing Date
EP21706540.8A Pending EP4106724A1 (de) 2020-02-18 2021-02-17 Glp-1-zusammensetzungen und verwendungen davon
EP21706537.4A Pending EP4106727A1 (de) 2020-02-18 2021-02-17 Pharmazeutische formulierungen
EP25154759.2A Pending EP4537848A3 (de) 2020-02-18 2021-02-17 Glp-1-zusammensetzungen und verwendungen davon
EP26163516.3A Pending EP4748398A3 (de) 2020-02-18 2021-02-17 Pharmazeutische formulierungen

Family Applications Before (3)

Application Number Title Priority Date Filing Date
EP21706540.8A Pending EP4106724A1 (de) 2020-02-18 2021-02-17 Glp-1-zusammensetzungen und verwendungen davon
EP21706537.4A Pending EP4106727A1 (de) 2020-02-18 2021-02-17 Pharmazeutische formulierungen
EP25154759.2A Pending EP4537848A3 (de) 2020-02-18 2021-02-17 Glp-1-zusammensetzungen und verwendungen davon

Country Status (15)

Country Link
US (6) US20230093542A1 (de)
EP (4) EP4106724A1 (de)
JP (4) JP7761567B2 (de)
KR (2) KR20220143036A (de)
CN (7) CN115135305B (de)
AU (3) AU2021208601B2 (de)
BR (2) BR112022013746A2 (de)
CA (3) CA3304331A1 (de)
CL (1) CL2022002084A1 (de)
CO (2) CO2022010915A2 (de)
IL (2) IL294521A (de)
MX (2) MX2022009523A (de)
PE (2) PE20230819A1 (de)
TW (2) TWI878456B (de)
WO (2) WO2021144476A1 (de)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112020002804A2 (pt) 2017-08-24 2020-07-28 Novo Nordisk A/S composição farmacêutica líquida, e, kit
WO2020180534A1 (en) 2019-03-01 2020-09-10 President And Fellows Of Harvard College Methods and compositions for protein delivery
CA3154744A1 (en) 2019-11-06 2021-05-14 Sarah FRIEDRICH Glp-1 receptor agonists in dementia
IL294521A (en) * 2020-02-18 2022-09-01 Novo Nordisk As glp-1 compounds and their uses
US11478533B2 (en) 2020-04-27 2022-10-25 Novo Nordisk A/S Semaglutide for use in medicine
EP4313211A1 (de) * 2021-03-30 2024-02-07 SCHOTT Pharma Schweiz AG System zur niedrigtemperaturlagerung einer pharmazeutischen zusammensetzung, flüssige zusammensetzung, verfahren und verwendungen
CA3237751A1 (en) 2021-11-10 2023-05-19 Tyler Brown Ionic liquid compositions
CN114249808B (zh) * 2021-12-27 2024-11-12 江苏诺泰澳赛诺生物制药股份有限公司 一种Cagrilintide的合成方法
CN114660214B (zh) * 2022-02-18 2024-04-05 兰州积石药业有限公司 一种司美格鲁肽的液相色谱检测方法及其应用
CN116763763B (zh) * 2022-12-05 2024-08-30 齐鲁制药有限公司 一种司美格鲁肽吸入喷雾剂及其制备方法
CN116159027A (zh) * 2022-12-29 2023-05-26 江苏诺泰澳赛诺生物制药股份有限公司 一种司美格鲁肽冻干药物组合物及其制备方法
EP4646187A1 (de) 2023-01-06 2025-11-12 Nano Precision Medical, Inc. Formulierungen, vorrichtungen und verfahren für einen glp-1-agonisten
EP4721730A1 (de) * 2023-06-02 2026-04-08 G2GBIO, Inc. Pharmazeutische zusammensetzung mit retard-mikrokügelchen mit cagrilintid oder einem pharmazeutisch akzeptablen salz davon und herstellungsverfahren dafür
AU2024305247A1 (en) * 2023-06-15 2025-12-11 Novo Nordisk A/S Pharmaceutical formulations of an amylin receptor agonist and a glp-1 receptor agonist comprising a cyclodextrin
US20260007869A1 (en) 2023-06-23 2026-01-08 Vaxess Technologies, Inc. Microneedle array patches (maps), systems, and methods for manufacturing and using same
WO2026044024A1 (en) * 2024-08-21 2026-02-26 I2O Therapeutics, Inc. Compositions comprising combinations of pharmaceutically acceptable salts and other derivatives of glucagon-like peptide-1 receptor agonist and pharmaceutically acceptable salts and other derivatives of amylin analog, and uses thereof
WO2026083250A1 (en) * 2024-10-14 2026-04-23 Orbicular Pharmaceutical Technologies Private Limited Article of manufacture for semaglutide compositions
US20260199436A1 (en) * 2025-01-16 2026-07-16 Novo Nordisk A/S Semaglutide in medical therapy including weight management

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